Nasopharyngeal Cancinoma (NPC)Phase 2NCT07524413
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
A Phase 2 study testing Becotatug Vedotin, Pucotenlimab and Intensity-Modulated Radiotherapy in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy with becotatug vedotin (MRG003) plus pucotenlimab, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
- What is being tested?
- Becotatug Vedotin, Pucotenlimab and Intensity-Modulated Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at diagnosis, regardless of sex.
- Previously untreated nasopharyngeal carcinoma histologically confirmed as non-keratinizing carcinoma according to the World Health Organization (WHO) classification.
- Locoregionally advanced nasopharyngeal carcinoma classified as stage II or III, excluding T3N0-1 disease, according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) clinical staging system.
- Positive plasma Epstein-Barr virus (EBV) DNA before initiation of treatment (> 0 copies/mL).
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Willing to provide an archived tumor tissue specimen from the primary or metastatic lesion obtained within the previous 2 years or a fresh tumor tissue specimen. Participants who are unable to provide a tumor tissue specimen may still be enrolled at the investigator's discretion, provided all other eligibility criteria are met.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment.
- Adequate organ function meeting the following criteria, without blood transfusion, any hematopoietic growth factor, and/or thrombopoietic agent within the 4 weeks before the screening assessments:
- Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; white blood cell count > 4 × 10⁹/L; hemoglobin > 90 g/L; and platelet count > 100 × 10⁹/L.
- Hepatic and renal function: Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min; and urinary protein ≤ 2+ or ≤ 1,000 mg/24 hours.
- Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Stable low-dose anticoagulant therapy, such as aspirin 100 mg/day, is permitted.
- Normal results for thyroid function, serum amylase and lipase, pituitary function, inflammatory and infectious markers, cardiac enzymes, and electrocardiography (ECG):
- Patients aged > 50 years with a smoking history must have normal pulmonary function test results.
- Patients with ECG abnormalities or a history of cardiovascular disease that does not meet any condition listed in Exclusion Criterion 5 must additionally undergo myocardial function testing and echocardiography, with normal results required for enrollment.
- Patients must provide written informed consent and be willing and able to comply with all protocol-specified follow-up visits, treatments, laboratory assessments, and other study requirements.
- Male patients with reproductive potential and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form through 6 months after the last dose of study drug. Women of childbearing potential include premenopausal women and women who have been postmenopausal for less than 2 years. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of study drug.
Who cannot join
- Patients meeting any of the following criteria will be excluded from the study:
- Current or previous history of another malignancy within the past 5 years, except for cured cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin.
- Negative plasma Epstein-Barr virus (EBV) DNA before initiation of treatment (= 0 copies/mL) or absence of pretreatment plasma EBV DNA testing.
- Prior receipt of any antitumor therapy for nasopharyngeal carcinoma or any of the following treatments:
- Any antibody-drug conjugate (ADC) containing a monomethyl auristatin E (MMAE) payload within 3 months before the first dose of study treatment.
- Any investigational drug from another clinical trial within 28 days before the first dose of study treatment.
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- Major surgery within 28 days before the first dose of study treatment without complete recovery, or planned major surgery within the first 12 weeks after initiation of study treatment.
- Positive human immunodeficiency virus antibody (HIV-Ab); active tuberculosis; active hepatitis B virus infection (HBV DNA > 1 × 10³ copies/mL); or positive hepatitis C virus antibody.
- History of primary immunodeficiency or active autoimmune disease requiring immunosuppressive agents or systemic corticosteroid therapy at a dose of ≥ 10 mg/day of prednisone or an equivalent corticosteroid within 2 weeks before enrollment. The following conditions or treatments are permitted: type 1 diabetes mellitus; hypothyroidism, including hypothyroidism caused by autoimmune thyroid disease, that is stable on hormone replacement therapy; psoriasis, vitiligo, or alopecia not requiring systemic treatment; topical or inhaled corticosteroids; or short-term systemic corticosteroid therapy lasting ≤ 7 days for the prevention or treatment of non-autoimmune, non-recurrent allergic conditions.
- Uncontrolled cardiac disease, including any of the following:
- Heart failure of New York Heart Association (NYHA) Class ≥ II.
- Unstable angina.
- Myocardial infarction within the past year.
- Prolonged QT interval, defined as QTc > 450 msec in males or > 470 msec in females; complete left bundle branch block; third-degree atrioventricular block; or supraventricular or ventricular arrhythmia requiring treatment or intervention.
- Hypertension inadequately controlled with two antihypertensive agents, defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg.
- Poorly controlled blood glucose, defined as either of the following, or concurrent diabetic gangrene:
- Fasting blood glucose > 10 mmol/L on two occasions.
- Glycated hemoglobin (HbA1c) > 8%.
- History of noninfectious interstitial lung disease (ILD) or pneumonitis requiring corticosteroid treatment, including pulmonary fibrosis or radiation pneumonitis; current ILD or pneumonitis; or imaging findings at screening that cannot exclude suspected ILD or pneumonitis.
- Concurrent pulmonary disease causing clinically severe respiratory impairment, including but not limited to:
- Any underlying pulmonary disease, such as pulmonary embolism, severe asthma, or severe chronic obstructive pulmonary disease (COPD), occurring within 3 months before screening.
- Restrictive lung disease.
- History of or concurrent interstitial pneumonitis, radiation pneumonitis, severe COPD, severe pulmonary insufficiency, symptomatic bronchospasm, or a similar pulmonary condition.
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening, including deep vein thrombosis, arterial thrombosis, or pulmonary embolism. Infusion catheter-related thrombosis is exempt.
- Pregnant or breastfeeding women. Pregnancy testing should be considered for sexually active women of childbearing potential.
- Known hypersensitivity to any component of pucotenlimab or becotatug vedotin (MRG003), including histidine, histidine hydrochloride, sucrose, mannitol, or polysorbate 80; or a history of a Grade ≥ 3 hypersensitivity reaction to any macromolecular protein preparation or monoclonal antibody.
- Serious infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade > 2 within 4 weeks before the first dose of study treatment, including but not limited to severe pneumonia, bacteremia, sepsis, or tuberculosis.
- Peripheral neuropathy of Grade > 1.
- Receipt of a live vaccine within 30 days before the first dose of becotatug vedotin (MRG003).
- Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Any other condition judged by the investigator to potentially compromise patient safety or compliance, including but not limited to a serious medical condition requiring prompt treatment, including a psychiatric disorder; markedly abnormal laboratory findings; or other psychological, familial, or social high-risk factors.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective Study of Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade Guided by Dynamic Plasma Cell-Free EBV DNA in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy with becotatug vedotin (MRG003) plus pucotenlimab, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic response in patients with locoregionally advanced nasopharyngeal carcinoma.
All participants will receive three cycles of induction therapy with becotatug vedotin (MRG003) plus the PD-1 inhibitor pucotenlimab. After induction therapy, participants with cfEBV DNA clearance and a complete or partial response will be classified as low risk and receive intensity-modulated radiotherapy alone, followed by adjuvant pucotenlimab. Participants without cfEBV DNA clearance or with stable or progressive disease will be classified as high risk and receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant pucotenlimab and capecitabine.
The primary objectives are to evaluate the post-induction therapy complete response rate in the overall study population and event-free survival in the high-risk group.
Read the detailed description
This is a multicenter, prospective study evaluating a biomarker- and response-guided risk-adapted treatment strategy for locoregionally advanced nasopharyngeal carcinoma.
All participants will receive three cycles of induction therapy with becotatug vedotin (MRG003), an epidermal growth factor receptor-directed antibody-drug conjugate, plus the PD-1 inhibitor pucotenlimab. Risk assignment will be performed after completion of induction therapy using both plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic tumor response.
Participants with undetectable cfEBV DNA and a complete or partial response after induction therapy will be assigned to the low-risk group. These participants will then receive intensity-modulated radiotherapy without concurrent cisplatin, followed by adjuvant pucotenlimab.
Participants with detectable cfEBV DNA after induction therapy, or whose best radiographic response is stable or progressive disease, will be assigned to the high-risk group. These participants will receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant pucotenlimab and capecitabine.
The study has two primary objectives: to evaluate the complete response rate after induction therapy in the overall study population and to evaluate event-free survival in the higher-risk group. Secondary evaluations include overall survival, distant metastasis-free survival, locoregional recurrence-free survival, cfEBV DNA clearance after induction therapy, safety, tolerability, and patient-reported quality of life.
Exploratory analyses will investigate potential prognostic and treatment-response biomarkers in tumor tissue, blood, and stool samples. Clinical outcomes will also be explored across subgroups defined by age, sex, baseline cfEBV DNA level, percentage reduction or clearance of cfEBV DNA, clinical stage, and other relevant prognostic factors.
- Being tested
- Becotatug Vedotin, Pucotenlimab, Intensity-Modulated Radiotherapy, Cisplatin, Capecitabine
- Keywords
- PD-1 antibody, Antibody-Drug Conjugate, MRG003, Becotatug Vedotin, Pucotenlimab
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Induction Therapy: Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 (3 cycles, Q3W)
PucotenlimabDrug
Induction Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (3 cycles, Q3W);
Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (5 cycles, Q3W)
Intensity-Modulated RadiotherapyRadiation
70 Gy in 33 fractions, once daily, 5 days per week
CisplatinDrug
Concurrent Chemoradiotherapy: Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W)
CapecitabineDrug
Adjuvant Therapy: Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W)
| Study group | Role | What they receive |
|---|---|---|
| Low-Risk Group | Experimental | Participants with undetectable plasma cfEBV DNA and a radiographic complete response or partial response after three cycles of induction therapy [Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W] are classified as low risk and receive the following treatment: Radiotherapy Alone: Intensity-modulated radiotherapy (IMRT), 70 Gy in 33 fractions, once daily, 5 days per week; Adjuvant Immunotherapy (5 cycles, Q3W): Pucotenlimab 200 mg, intravenous infusion, Day 1. Receives: Drug: Becotatug Vedotin; Drug: Pucotenlimab; Radiation: Intensity-Modulated Radiotherapy |
| High-Risk Group | Experimental | Participants with detectable plasma cfEBV DNA or a radiographic response of stable disease or progressive disease after three cycles of induction therapy [Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W] are classified as high risk and receive the following treatment: Concurrent Chemoradiotherapy (CCRT): IMRT, 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) + Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W). Receives: Drug: Becotatug Vedotin; Drug: Pucotenlimab; Radiation: Intensity-Modulated Radiotherapy; Drug: Cisplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction Therapy Complete Response Rate (post-IT CRR)
The proportion of patients achieving complete response following induction therapy
Measured: Within 9 to 21 days after the last dose of induction therapy
Event-Free Survival (EFS) in the High-Risk Group
The time from the date of enrollment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
Measured: 3 years & 5 years
Secondary outcomes (8)
Overall survival (OS)
From date of enrollment to date of death from any cause
Measured: 3 years & 5 years
Distant Metastasis-Free Survival (DMFS)
From the date of enrollment to the date of first documented distant metastasis or death from any cause, whichever occurs first.
Measured: 3 years & 5 years
Locoregional Recurrence-Free Survival (LRRFS)
From the date of enrollment to the date of first documented locoregional recurrence or death from any cause, whichever occurs first.
Measured: 3 years & 5 years
Adverse Events (AEs)
Graded according to CTCAE V5.0
Measured: 3 years & 5 years
Patient-Reported Adverse Events (PRO-CTCAE)
Patient-reported adverse events will be assessed using selected items from the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE™), Chinese version, administered at each treatment cycle. Patients will self-report and rate the severity of relevant adverse events throughout the study treatment period.
Measured: At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 5 of adjuvant therapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Assesses general quality of life in cancer patients. Items are scored and linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Assesses head and neck cancer-specific symptoms. Items are scored and linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)
Assesses quality of life specific to head and neck cancer patients. Items are rated on a 0-4 scale and summed to a total score of 0-156. Higher scores indicate better quality of life.
Measured: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive the same induction therapy and are subsequently stratified into low- and high-risk groups according to post-induction cfEBV DNA status and radiographic response, with each group receiving its protocol-defined treatment.
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524413
- Sponsor's protocol ID
- 2025-FXY-502-FLK
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study of Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade Guided by Dynamic Plasma Cell-Free EBV DNA in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07524413
- Acronym / sponsor ID
- 2025-FXY-502-FLK
- Keywords
- PD-1 antibody, Antibody-Drug Conjugate, MRG003, Becotatug Vedotin, Pucotenlimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of a risk-adapted treatment strategy incorporating induction therapy with becotatug vedotin (MRG003) plus pucotenlimab, followed by treatment allocation based on post-induction plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic response in patients with locoregionally advanced nasopharyngeal carcinoma.
All participants will receive three cycles of induction therapy with becotatug vedotin (MRG003) plus the PD-1 inhibitor pucotenlimab. After induction therapy, participants with cfEBV DNA clearance and a complete or partial response will be classified as low risk and receive intensity-modulated radiotherapy alone, followed by adjuvant pucotenlimab. Participants without cfEBV DNA clearance or with stable or progressive disease will be classified as high risk and receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant pucotenlimab and capecitabine.
The primary objectives are to evaluate the post-induction therapy complete response rate in the overall study population and event-free survival in the high-risk group.
Detailed description
This is a multicenter, prospective study evaluating a biomarker- and response-guided risk-adapted treatment strategy for locoregionally advanced nasopharyngeal carcinoma.
All participants will receive three cycles of induction therapy with becotatug vedotin (MRG003), an epidermal growth factor receptor-directed antibody-drug conjugate, plus the PD-1 inhibitor pucotenlimab. Risk assignment will be performed after completion of induction therapy using both plasma cell-free Epstein-Barr virus DNA (cfEBV DNA) status and radiographic tumor response.
Participants with undetectable cfEBV DNA and a complete or partial response after induction therapy will be assigned to the low-risk group. These participants will then receive intensity-modulated radiotherapy without concurrent cisplatin, followed by adjuvant pucotenlimab.
Participants with detectable cfEBV DNA after induction therapy, or whose best radiographic response is stable or progressive disease, will be assigned to the high-risk group. These participants will receive intensity-modulated radiotherapy with concurrent cisplatin, followed by adjuvant pucotenlimab and capecitabine.
The study has two primary objectives: to evaluate the complete response rate after induction therapy in the overall study population and to evaluate event-free survival in the higher-risk group. Secondary evaluations include overall survival, distant metastasis-free survival, locoregional recurrence-free survival, cfEBV DNA clearance after induction therapy, safety, tolerability, and patient-reported quality of life.
Exploratory analyses will investigate potential prognostic and treatment-response biomarkers in tumor tissue, blood, and stool samples. Clinical outcomes will also be explored across subgroups defined by age, sex, baseline cfEBV DNA level, percentage reduction or clearance of cfEBV DNA, clinical stage, and other relevant prognostic factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants receive the same induction therapy and are subsequently stratified into low- and high-risk groups according to post-induction cfEBV DNA status and radiographic response, with each group receiving its protocol-defined treatment.
| Arm | Type | Receives |
|---|---|---|
| Low-Risk Group | Experimental | Drug: Becotatug Vedotin, Drug: Pucotenlimab, Radiation: Intensity-Modulated RadiotherapyParticipants with undetectable plasma cfEBV DNA and a radiographic complete response or partial response after three cycles of induction therapy [Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W] are classified as low risk and receive the following treatment: Radiotherapy Alone: Intensity-modulated radiotherapy (IMRT), 70 Gy in 33 fractions, once daily, 5 days per week; Adjuvant Immunotherapy (5 cycles, Q3W): Pucotenlimab 200 mg, intravenous infusion, Day 1. |
| High-Risk Group | Experimental | Drug: Becotatug Vedotin, Drug: Pucotenlimab, Radiation: Intensity-Modulated Radiotherapy, Drug: Cisplatin, Drug: CapecitabineParticipants with detectable plasma cfEBV DNA or a radiographic response of stable disease or progressive disease after three cycles of induction therapy [Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W] are classified as high risk and receive the following treatment: Concurrent Chemoradiotherapy (CCRT): IMRT, 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) + Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years at diagnosis, regardless of sex.
- Previously untreated nasopharyngeal carcinoma histologically confirmed as non-keratinizing carcinoma according to the World Health Organization (WHO) classification.
- Locoregionally advanced nasopharyngeal carcinoma classified as stage II or III, excluding T3N0-1 disease, according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) clinical staging system.
- Positive plasma Epstein-Barr virus (EBV) DNA before initiation of treatment (> 0 copies/mL).
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Key exclusion criteria (31 listed)
- Current or previous history of another malignancy within the past 5 years, except for cured cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin.
- Negative plasma Epstein-Barr virus (EBV) DNA before initiation of treatment (= 0 copies/mL) or absence of pretreatment plasma EBV DNA testing.
- Prior receipt of any antitumor therapy for nasopharyngeal carcinoma or any of the following treatments:
- Positive human immunodeficiency virus antibody (HIV-Ab); active tuberculosis; active hepatitis B virus infection (HBV DNA > 1 × 10³ copies/mL); or positive hepatitis C virus antibody.
- History of primary immunodeficiency or active autoimmune disease requiring immunosuppressive agents or systemic corticosteroid therapy at a dose of ≥ 10 mg/day of prednisone or an equivalent corticosteroid within 2 weeks before enrollment. The following conditions or treatments are permitted: type 1 diabetes mellitus; hypothyroidism, including hypothyroidism caused by autoimmune thyroid disease, that is stable on hormone replacement therapy; psoriasis, vitiligo, or alopecia not requiring systemic treatment; topical or inhaled corticosteroids; or short-term systemic corticosteroid therapy lasting ≤ 7 days for the prevention or treatment of non-autoimmune, non-recurrent allergic conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug VedotinInduction Therapy: Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 (3 cycles, Q3W) | Drug | High-Risk Group, Low-Risk Group |
| PucotenlimabInduction Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) | Drug | High-Risk Group, Low-Risk Group |
| Intensity-Modulated Radiotherapy70 Gy in 33 fractions, once daily, 5 days per week | Radiation | High-Risk Group, Low-Risk Group |
| CisplatinConcurrent Chemoradiotherapy: Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W) | Drug | High-Risk Group |
| CapecitabineAdjuvant Therapy: Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W) | Drug | High-Risk Group |
Primary outcome
Post-induction Therapy Complete Response Rate (post-IT CRR)
Time frame: Within 9 to 21 days after the last dose of induction therapy
The proportion of patients achieving complete response following induction therapy
Event-Free Survival (EFS) in the High-Risk Group
Time frame: 3 years & 5 years
The time from the date of enrollment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause.
8 secondary outcomes
Overall survival (OS)
Time frame: 3 years & 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years & 5 years
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: 3 years & 5 years
Adverse Events (AEs)
Time frame: 3 years & 5 years
Patient-Reported Adverse Events (PRO-CTCAE)
Time frame: At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 5 of adjuvant therapy
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)
Time frame: At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Platinum-Free Regimen in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Active, not recruitingPhase 3
Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.
Nasopharyngeal Cancinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin, Pucotenlimab and Intensity-Modulated Radiotherapy in people with Nasopharyngeal Cancinoma (NPC) and Nasopharyngeal Cancer, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Ma (+862087343469, majun2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction Therapy Complete Response Rate (post-IT CRR) (time frame: Within 9 to 21 days after the last dose of induction therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.